Safety and Efficacy of Brimonidine Tartrate/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01229462
First received: October 26, 2010
Last updated: August 15, 2012
Last verified: August 2012
  Purpose

This study will evaluate the safety and efficacy of brimonidine tartrate/timolol fixed combination (Combigan®) compared with brimonidine tartrate (Alphagan®) and timolol in patients with glaucoma or ocular hypertension who do not respond well to topical beta blockers.


Condition Intervention
Glaucoma
Ocular Hypertension
Drug: brimonidine tartrate/timolol fixed combination ophthalmic solution
Drug: brimonidine tartrate ophthalmic solution
Drug: timolol ophthalmic solution
Other: fixed combination vehicle

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4 [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
    Intraocular pressure (IOP) was measured in the study eye at baseline and Week 4. IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement).


Enrollment: 238
Study Start Date: October 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Combigan®
One drop of brimonidine tartrate/timolol combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.
Drug: brimonidine tartrate/timolol fixed combination ophthalmic solution
One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) administered to the affected eye(s) twice daily (morning and evening) for four weeks.
Other Name: Combigan®
Other: fixed combination vehicle
Fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.
Active Comparator: Alphagan® and Timolol Concurrent
One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
Drug: brimonidine tartrate ophthalmic solution
One drop of brimonidine tartrate ophthalmic solution (Alphagan®) administered to the affected eye(s) twice daily (morning and evening) for four weeks.
Other Name: Alphagan®
Drug: timolol ophthalmic solution
One drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Open-angle glaucoma or ocular hypertension in at least one eye that is not responsive to topical beta blockers
  • No anticipated wearing of contact lenses during study

Exclusion Criteria:

  • Active ocular disease other than glaucoma or ocular hypertension (eg, uveitis, ocular infections or severe dry eye)
  • Any intraocular surgery or laser (eg, cataract surgery or Lasik) within 3 months
  • Required regular use of other ocular medications except for occasional use of artificial tears
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01229462

Locations
China, Guangdong
Guangzhou, Guangdong, China
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01229462     History of Changes
Other Study ID Numbers: 190342-035
Study First Received: October 26, 2010
Results First Received: August 15, 2012
Last Updated: August 15, 2012
Health Authority: China: State Food and Drug Administration P.R. China (SFDA)

Additional relevant MeSH terms:
Glaucoma
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Timolol
Brimonidine
Ophthalmic Solutions
Pharmaceutical Solutions
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists

ClinicalTrials.gov processed this record on August 25, 2014